Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT02526602
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2015-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preservation of Endopelvic Fascia: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
Sponsor:
Tampere University Hospital
Organization:
Study Overview
Official Title:
Preservation of Endopelvic Fascia During Radical Prostatectomy: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Urinary incontinence and impotence are typical disturbances after radical prostatectomy. Although, several surgical methods are developed to decrease these disturbances, 8% and 50% of the patients suffer from permanent urinary incontinence and impotence, respectively.
Previously two studies have shown that endopelvic fascia preservation may decrease postoperative incontinence and impotence rates. Unfortunately these studies are retrospective decreasing their reliability.
The present study is prospective and randomized clinical trial. The investigators are going to randomize 180 patient to preservation and opening the endopelvic fascia groups. Functional and oncological results are followed up to 1 year after surgery.
Previously two studies have shown that endopelvic fascia preservation may decrease postoperative incontinence and impotence rates. Unfortunately these studies are retrospective decreasing their reliability.
The present study is prospective and randomized clinical trial. The investigators are going to randomize 180 patient to preservation and opening the endopelvic fascia groups. Functional and oncological results are followed up to 1 year after surgery.
Detailed Description:
180 patients going to radical prostatectomy as treatment of prostate cancer will be randomized 1:1 to two study arms: In the other arm endopelvic fascia are preserved during the operation, in the other arm the fascia are opened.
After the operation urinary continence and erection function are compared between the study arms. Additionally the investigators will study oncological outcomes.
After the operation urinary continence and erection function are compared between the study arms. Additionally the investigators will study oncological outcomes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: